Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil

NCT02600767 | Completed Results DMC

• 1 other identifier: CDC-CGH-2015-204
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions. The results of this efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to evaluate the national policy for treatment of malaria caused by P. falciparum.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Absence of Malaria Parasites in Blood.

  Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.

  28 days

Study Arms (1)

Artemether-Lumefantrine

OTHER

Three days of standard treatment. This is a standard combination therapy for the treatment of P. falciparum malaria.

Drug: Artemether-lumefantrine combination

Interventions

Artemether-lumefantrine combination DRUG

This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.

Also known as: Coartem

Artemether-Lumefantrine

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 5 years
• body weight \< 120kg
• documented fever (axillary temperature ≥37.5o C) or history of fever in the previous 48 hours in the absence of other obvious causes of fever, such as pneumonia, middle ear infection, etc.
• monoinfection by P. falciparum with parasitemia between 250 and 200,000 asexual parasites/µl, as determined by swab and thick peripheral blood smear microscopic exam
• patient or parent/caregiver able to comprehend and sign informed consent or permission form
• patients aged 7-17 years able to provide assent, patients aged 5-6 years do not require assent
• willingness to return to the clinic and/or accept home visits for regular check-ups during the 28-day follow-up period
• hemoglobin level ≥8 g/dl

You may not qualify if:

• presence of malaria danger signs (inability to drink, vomiting (more than twice in the previous 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand up); presence of signs of severe malaria (altered level of consciousness, psychomotor alteration, seizure, torpor and irreversible coma), severe anemia (hematocrit \< 15% or clinical signs, hemoglobin \<5 g/dl), renal failure (serum creatinine \> 3 mg/dl or clinical signs), pulmonary edema, hypoglycemia (blood glucose \< 40 mg/dl or clinical signs), shock (systolic blood pressure \< 70 mmHg for adults; \< 50 mmHg for children), spontaneous hemorrhage/disseminated intravascular coagulation, repeated generalized seizures, acidemia/acidosis (clinical signs), macroscopic hemoglobinuria, and jaundice.
• history of chronic or severe underlying diseases (e.g. heart, renal or liver diseases, HIV/AIDS, tuberculosis, malnourishment)
• history of hypersensitivity to AL
• current pregnancy (history of current pregnancy or positive pregnancy test)
• use of any antimalarial drug in the previous 30 days.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Secretaria Estadual de Saúde do Acre: collaborator
• Ministry of Health, Brazil: collaborator
• Evandro Chagas National Institute of Infectious Disease: collaborator

Study Sites (1)

Hospital do Jurua

Cruzeiro do Sul, Brazil

Location

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Alexandre Macedo de Oliveira
• Organization: CDC

acq7@cdc.gov

404 718 4751

Study Officials

• Alexandre Macedo de Oliveira, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Evaluation of the efficacy of artemether and lumefantrine for uncomplicated P. falciparum malaria.

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: November 9, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 9, 2017
• Results First Posted: October 9, 2017

Record last verified: 2015-10

Locations

BR (1)